Virtual Risk Assessment for Potent Compound Safety and Handling

Risk assessments for potent compound safety handling and design review are critical for laboratories, pilot plants, manufacturing plants, and packaging and labeling facilities. Selecting a qualified occupational health and safety consulting firm to conduct the risk assessment is vital. There are several top factors listed below that qualify Affygility Solutions as your occupational health and safety service partner.

Can a risk assessment of a facility be done virtually?

Risk assessments for potent compound safety handling and design review can be done virtually! With advances in video conferencing tools, the Affygility team has experience in performing virtual risk assessments for laboratories, pilot plants, manufacturing plants, and packaging and labeling facilities. The core process of the review remains the same regardless if it’s conducted in-person or virtually, but conducting a review virtually can save time and money. The Affygility team is experienced at navigating the nuances of a virtual review.

What are the benefits of a virtual risk assessment?

• Increases the flexibility with timing and scheduling since travel arrangements are not a factor.
• The overall cost of a virtual risk assessment is lower than an in-person assessment.

How is the facility toured through a virtual risk assessment?

An occupational health and safety expert from Affygility’s experienced team will conduct a virtual tour of the facility using video conferencing tools. Technical and equipment guidelines will be provided prior to the assessment. The duration of the tour can range from one hour to eight hours depending on various factors including the size, the age, and the type of facility, the existing protective equipment and engineering controls within the facility, and the different products handled.

Is any documentation reviewed during the risk assessment?

An occupational health and safety expert from Affygility’s experienced team will review the appropriate documentation including, but not limited to:

• Current written SOPs related to potent compound safety and handling in the facility
• Banding and categorization schemes
• OEL/PDE/ADE reports for each molecule applicable to the assessment
• Facility layout including personal and equipment flow
• HVAC system/pressure differential/airlocks etc.
• Personal protective equipment
• Equipment design and existing engineering controls
• Any current or outstanding compliance findings, related to potent compound safety or cross-contamination, issued by recognized governmental agencies

Are there any prerequisites prior to the virtual risk assessment?

Prior to the virtual risk assessment being scheduled, a video conference will be coordinated to determine the scope of the assessment, the products being handled, and the type of facility to be assessed.

It is also critical to have an OEL/ADE report for each molecule applicable to the assessment. If OEL/ADE reports are needed, Affygility offers a CPhI and HPAPI award-winning web-based ordering platform, OEL Fastrac, for purchasing OEL/ADE reports. The OEL Fastrac catalog contains nearly 2,000 existing reports. If a custom OEL/ADE report is needed, the certified toxicology team at Affygility can also assist.

What isn’t included in the review?

The virtual assessment is an evaluation of the client’s current work practices, procedures, and controls related to potent compound safety practices. Also, the assessment is an identification of potential gaps in processes and does not include the development of a corrective action plan. Below is a sample list of what is not included in the review. More details can be provided during the initial meeting.

• The assessment will not cover environmental regulations related to air emissions permitting, stormwater and industrial wastewater permitting, or hazardous waste management.
• In addition, the assessment will not include any onsite activities, the collection of environmental or industrial hygiene air or surface samples, and the review of client’s compliance with other industrial safety regulations such as bloodborne pathogens, occupational noise, lockout/tagout, machine guarding, or fall protection standards.
• The project will include review/comments on the client’s existing standard operating procedures (SOPs) but will not include any authoring/rewriting of SOPs.

Is a written report provided?

An occupational health and safety expert from Affygility’s experienced team prepares a comprehensive written report including:

• Scope of the assessment
• List of documents and items reviewed
• Prioritization and classification of findings, including a table of findings. The table summarizes the findings of the assessment, the recommendations, and provides a priority assignment.

What risk assessment tools are used during the review?

For all virtual risk assessments, Affygility uses Affytrac, a proprietary web-based EHS management system for the life science industry. This tool is used throughout the process to share critical information and for generating reports.

Does Affygility have an experienced staff?

Since 2002, Affygility has been providing potent compound safety, occupational toxicology, and industrial hygiene services to biotechnology, pharmaceutical, and medical device companies throughout the world. The team has decades of experience in the pharmaceutical industry and maintains certifications including CIH, DABT and ERT.

How to get started

Contact us to discuss how Affygility can be your trusted occupational health and safety service partner to conduct a virtual risk assessment for potent compound safety and handling.

Schedule your virtual risk assessment today!